OS Therapies has reached agreement with the FDA, MHRA, and EMA on an adaptive design for its Phase 3 trial of OST-HER2, a gene-edited cancer immunotherapy targeting metastatic osteosarcoma. The company will start this trial in late 2026 and plans a key FDA meeting after submitting 3-year survival data. OS Therapies also accepted MHRA's request to lead its participation in Project Orbis, a global initiative to speed up oncology drug approvals through coordinated regulatory reviews. OST-HER2 holds multiple designations including Orphan Drug and Fast Track, and if approved, OS Therapies could receive a valuable Priority Review Voucher to sell. This alignment and Project Orbis involvement aim to accelerate OST-HER2's availability in the US, UK, and Europe.
OS Therapies' recent regulatory progress is provided here with a snapshot of the Health sector on Pluang as of Sep 17, 2026 17:02 WIB: Among 91 priced US health stocks, 59 rose and 27 fell. Ascendis Pharma (ASND) traded at USD 239.50 with a 3.31% decline and a strong 91% sell order activity, contrasting with Sana Biotechnology (SANA) at USD 3.00 gaining 2.74% but seeing 86% sell orders. American Well Corp (AMWL) rose 2.03% to USD 13.60, holding the longest typical Pluang hold time of 61 days in this group.
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